Regulatory Submissions, Information, and Document Management Forum

What is happening at Regulatory Submissions, Information, and Document Management Forum

• Event Goals and Offerings

  • Gather insights to hot topics impacting regulatory information in life sciences research and development
  • Hear directly from global regulators on regulatory plans, priorities, and updates to incorporate into your everyday work and processes
  • Identify how advanced technologies and innovation can be applied to impact functions and processes within regulatory affairs

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• Why You Can’t Miss It

  • Network with like-minded professionals focused on regulatory information in life sciences research and development to discuss best practices and lessons learned
  • Learn how to apply successful use cases, real-world examples, and practical outcomes into your own company or organization
  • Gain insights and discuss how stakeholders are impacted by everyday challenges and how they overcome these challenges
  • Evaluate future applications of regulatory informatics, trial master file inspection readiness, electronic document management, and electronic regulatory submissions

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  • Four educational tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Electronic Regulatory Submissions (ERS), Trial Master File (TMF) Inspection Readiness and Electronic Document Management (EDM)
  • Live Exhibit Hall
  • One full day Preconference Primer *Additional fee required
  • February 12, 2023 | In-Person - 10:00AM-5:00PM ET Regulatory Content and Submission Primer: Content from Authoring to Archive
  • Two Half day Preconference Short Courses *Additional fee required!
    • February 9, 2023 | Virtual - 10:00AM-2:00PM ET The Future of Documents: Deep-Dive into Structured Content
    • February 10, 2023 | Virtual - 10:00AM-2:00PM ET On the Road to an EU Filing: Getting Familiar with Critical EMA IT Systems

  Receive $150 off your forum registration by registering for any combination of at least two short courses and/or primer as well as the main forum. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

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  Track 1: Regulatory Informatics Business

  Addresses the governance, processes and standards around life cycle management of regulatory data, including key challenges shaping the global regulatory and business environments.

  
  

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  Track 2: Regulatory Informatics Technology

  Covers (emerging) technologies and solutions for data management & analytics to support efficient data control and quality, including hot topics such as Artificial Intelligence (AI) and Structured Content Management (SCM)

  
  

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  Track 3: Trial Master File (TMF) Inspection Readiness and Electronic Document Management (EDM)

  Track examines the processes, systems, and best practices for content management across the product lifecycle, including alignment with RIM systems for optimal use of regulatory information as well as the downstream impact on Inspection Readiness in the Trial Master File.

  
  
  

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  Track 4: Electronic Regulatory Submissions (ERS)

  Explores best practices, innovations, and future trends for creating and managing quality global submissions in an evolving regulatory landscape

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  Exhibitor Case Study Events

  February 14

  • 10:45-11:15AM Sponsored Session: Case Study hosted by Court Square Group / Adlib Software | The “Easy” Button for eTMF Classification: Using AI to Streamline Classification of Clinical Trial Documents!
  • 10:45-11:15AM Sponsored Session: Case Study hosted by Calyx
  • 3:30-4:14AM Sponsored Session: Case Study hosted by IQVIA | Reduce Time, Cost, and Risk, from Drug Discovery Through Post-Regulation

  February 15

  • 10:00-10:30AM Sponsored Session: Case Study hosted by ArisGlobal | Revolutionize Management of Global Lifecycle Submissions

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